Agarwal 2019.
Study characteristics | ||
Methods |
Mobile app for improved self‐management of type 2 diabetes: multicenter pragmatic randomized controlled trial RCT (NA clusters and NA providers), conducted in 1) Participants were recruited from 3 hospital‐based diabetes education programmes (DEPs) in Ontario, Canada. The 3 recruitment sites included (1) a DEP located in an urban area in a large city centre (> 2 million people), (2) 1 located in a midsize city in a remote area of the province (< 150,000 people), and (3) 1 located in a semi‐urban area surrounding a large city centre (< 600,000 people). These sites serve a diverse range of patients including a large immigrant community, rural patients and a large Aboriginal population. The services of these programmes are complementary to primary care delivered through the patients’ primary care provider (PCP) and usually do not include medication titration. 2) Intervention delivered remotely using a BlueStar mobile app. This app facilitated the transfer of data to the user’s clinician. In Canada 2 arms: 1) Control (WLC: wait‐list control) (control arm) and 2) Intervention (ITG: immediate BlueStar mobile app) (intervention arm) |
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Participants | Control arm N: 121 Intervention arm N: 119, NA, NA Diabetes type: 2 Mean age: 51.8 ± NR % Male: 52 Longest follow‐up: 3 months |
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Interventions |
Control arm: (WLC: wait‐list control) Intervention arm: (ITG: immediate BlueStar mobile app) 1) Electronic patient registry 2) Facilitated relay of clinical information 3) Patient education 4) Promotion of self‐management |
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Outcomes | 1) Glycated haemoglobin 2) Harms (hypoglycaemic episodes) |
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Funding source | Sponsor: Women's College Hospital (from protocol) | |
Notes | — | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Subject randomisation was computer‐generated and stratified by site, using block sizes of 2 or 4, through REDCap, a Web‐based electronic data entry system at the AHRC. |
Allocation concealment (selection bias) | Low risk | Randomisation was done in a centralised fashion by the Applied Health Research Centre (AHRC) at the Li Ka Shing Knowledge Institute of St. Michael’s Hospital in Toronto, Canada. |
Patient's baseline characteristics (selection bias) | Low risk | Table 1 summarises the demographic characteristics of the study population. There were no significant differences in patient characteristics including age, gender, ethnicity, education and household income. |
Patient's baseline outcomes (selection bias) | Unclear risk | Table 1) Data reported. No evidence of statistical test done. The average HbA1c level for the study population was 8.96% (SD 1.68) and was similar between the 2 study arms, and the use of insulin was similar between the 2 groups. |
Incomplete outcome data (attrition bias) | High risk | They have HbA1c data for 172 out of 240 patients randomised at baseline (28% lost) and 146 at 3 months (39% lost). The number of patients lost is 36% in the control group (44/121) and 42% in the intervention group (50/119) at 3 months follow up. |
Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) | Low risk | Primary outcome was objectively measured (HbA1c). Hypoglycaemic episodes were patient self‐reported and unlikely that they were blinded (but secondary outcomes). |
Selective reporting (reporting bias) | Low risk | Prospectively registered protocol. Some outcomes are not reported at 6 months follow‐up in the paper (ER visit, hypoglycaemic episodes, hospitalisations, physician visits). |
Risk of contamination (other bias) | Unclear risk | Patients RCT. Unlikely that control patients had access to the BlueStar mobile app before 3 months. However, since both groups were followed by clinicians from the same DEPs, clinicians could have change their approach with control patients after receiving data from the app of intervention patients. |
Other bias | Low risk | No evidence of other risk of bias |